NDC 71638-0009

Ultra Soothing Formula

Dimethicone

Ultra Soothing Formula is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Dermafirm Inc.. The primary component is Dimethicone.

Product ID71638-0009_68d656e4-9778-4fe2-e053-2a91aa0a9fab
NDC71638-0009
Product TypeHuman Otc Drug
Proprietary NameUltra Soothing Formula
Generic NameDimethicone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-04-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameDermafirm INC.
Substance NameDIMETHICONE
Active Ingredient Strength7 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71638-0009-1

200 mL in 1 BOTTLE, PUMP (71638-0009-1)
Marketing Start Date2018-04-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71638-0009-1 [71638000901]

Ultra Soothing Formula CREAM
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-02

Drug Details

Active Ingredients

IngredientStrength
DIMETHICONE7 g/100mL

OpenFDA Data

SPL SET ID:68d656e4-9777-4fe2-e053-2a91aa0a9fab
Manufacturer
UNII
UPC Code
  • 8809310535224

    • NDC Crossover Matching brand name "Ultra Soothing Formula" or generic name "Dimethicone"

    NDCBrand NameGeneric Name
    71638-0009Ultra Soothing FormulaUltra Soothing Formula
    0132-0326Boudreauxs Butt BarrierDimethicone
    0187-2218CeraVeDimethicone
    0187-2219CeraVedimethicone
    0187-2489CeraVedimethicone
    0299-4114Cetaphil Cracked Skin RepairDimethicone
    0299-4115Cetaphil Cracked Skin Repair BalmDimethicone
    0573-1935CHAPSTICK OVERNIGHTdimethicone
    0363-2247Daily BabyDimethicone
    0869-0354Daily BabyDimethicone
    0869-0496Daily BabyDimethicone
    0869-0619Daily MoisturizingDimethicone
    0363-5345Infants Gas ReliefDimethicone
    0363-5773Infants Gas ReliefDIMETHICONE
    0259-2202Mederma PMDimethicone
    0259-2102Mederma Stretch Marks Therapydimethicone
    0093-3204MoisturelDimethicone
    0430-3100MoisturelDimethicone
    10742-7005Softlipsdimethicone
    10742-7002Softlips Cherry, Raspberry, Vanilladimethicone
    10742-7003Softlips Watermelon, Tropical Coconut, Peach Passiondimethicone
    0132-8744Summers Eve Active ChafeDimethicone
    0187-1660TheraSealDimethicone
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